cGMP Regulations definition

cGMP Regulations means the applicable current Good Manufacturing Practices as promulgated by the FDA from time to time under the Act, as presently codified in 21 CFR Parts 210 and 211.
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cGMP Regulations means the applicable current Good Manufacturing Practices as promulgated under ICH Q7A-Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, U.S. Federal Food, Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV — rules governing medical products in the European Community 1989) in the most recent version.
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cGMP Regulations means the regulations defining and regulating current Good Manufacturing Practices (GMP) as contained from time to time in the Act and related regulations, or any successor laws or regulations governing the manufacture, handling, storage and control of the Product, including without limitations, regulations promulgated by the FDA under 21 C.F.R. §§ 210, 211, EC Directive 2003/94/EC, and the World Health Organization (WHO) “Guide to good manufacturing practice (GMP) requirements, and the International Conference on Harmonization (ICH), Guidance for Industry Q7A GMP Guidance for APIs.
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Examples of cGMP Regulations in a sentence

  • Hollister-Stier is responsible for formalxx xxxxxxxxxxxxg and documexxxxx xxx xxxxxres to follow or deviations from the Master Manufacturing Batch Production and Control Records or QC analytical testing methods or procedures, any test or in-process test which fails to meet Specifications and any failures of the equipment, utilities, facility or other systems used to manufacture the Intermediate and Product, in accordance with Hollister-Stier's procedures and cGMP Regulations.

  • Upon reasonable advance written notice to Unigene, Novartis, shall have the right to audit the manufacturing and warehousing operations of Unigene to assure that the operations are done in accordance with cGMP Regulations, subject to confidentiality requirements/agreements.

  • The Company’s related parties consist of the Company’s Directors and Officers, and any companies associated with them.

  • In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP Regulations, the provisions of the Quality Agreement shall govern.

  • Genzyme shall have the right to audit once annually each of those portions of the manufacturing, finish processing or storage facilities where Aldurazyme is being manufactured, finished or stored, or any subcontractor who is manufacturing, finishing or storing Aldurazyme for BioMarin, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the cGMP Regulations, as the same may be amended from time to time.

  • BioMarin shall have the right to audit once annually each of those portions of the distribution or storage facilities of Genzyme or its Affiliates where Aldurazyme is being stored, sold or distributed, or any subcontractor or other Third Party who is storing, selling or distributing Aldurazyme for Genzyme, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with cGMP Regulations, as the same may be amended from time to time.

  • Novartis shall have access to all mutually agreed upon relevant documentation (e.g. equipment qualification, calibration, etc.) related to cGMP Regulations and Manufacturing of the API.

  • Manufacturing is carried out according cGMP Regulations and Specifications.

  • Novartis shall have access to all mutually agreed upon relevant documentation (e.g. equipment qualification, calibration, etc.) related to cGMP Regulations and Manufacturing.

  • For Services to be performed in accordance with cGMP Regulations, the Parties agree to enter in a Quality Agreement between the Parties (or its Affiliates) that shall be incorporated herein by reference, as same may be amended from time to time by mutual written agreement between the Parties.


More Definitions of cGMP Regulations

cGMP Regulations means the current good manufacturing practices (“CGMP”) promulgated by the FDA, as amended, including those currently set out in Parts 210 and 211 of Title 21 of the Code of Federal Regulations. [***] Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. EXECUTION VERSION
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cGMP Regulations means the regulatory requirements for current good manufacturing practices with respect to the Processing, storage and Release Testing of Bulk Product under this Agreement, including (as applicable): the United States current Good Manufacturing Practices pursuant to the FDCA and pursuant to the relevant regulations found in Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 210, 211, 610 and 611), the European Union’s current Good Manufacturing Practices pursuant to EC Directive 2003/94/EC of 8 October 2003, and the International Conference on Harmonisation Guidance for Industry, as applicable, including Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, in the case of Q7 as applicable to the activities carried out by CoreRx under this Agreement, and any comparable regulatory requirements designated by the Parties in a Purchase Order, as such regulatory requirements may be amended from time to time.
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cGMP Regulations means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices, including but not limited to EU Directives 2003/94/EC code of GMP and 2001/83/EC as amended by 2004/27/EC code of practice for the QP, and all other relevant EU and UK principles and guidelines, ICH Tripartite Guidance Q7A and guidance documents relating to GMP and GDP as well as applicable US Current Good Manufacturing Practices (21 CFR 210 and 211) that govern the standards of manufacture for any product intended for human use, as appropriate.
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Related to cGMP Regulations

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164 subparts A and E (“The Privacy Rule”) and the Security Standards as they may be amended from time to time, 45 C.F.R. Parts 160, 162 and 164, Subpart C (“The Security Rule”).

  • UCITS Regulations means the European Communities (Undertakings for Collective

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • Privacy Regulations means the Privacy and Electronic Communications (EC Directive) Regulations 2003 as amended in 2004, 2011, 2015 and 2016 and as may be further amended from time to time;

  • OFAC Regulations means the regulations promulgated by OFAC, as amended from time to time.

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • Radio Regulations means the Radio Regulations annexed to, or regarded as being annexed to, the most recent International Telecommunication Convention which may be in force at any time.

  • EEA Regulations means the Immigration (European Economic Area) Regulations 2006.

  • the 2001 Regulations means the Water Supply (Water Quality) Regulations 2001[63];

  • OHS Regulation means the Workers Compensation Act (British Columbia), including without limitation, the Occupational Health & Safety Regulation (BC Regulation 296/97, as amended by BC Regulation 185/99) enacted pursuant to such Act, all as such Act or Regulations are amended or re-enacted from time to time.